A blog about what is new (and old) in the world of active implantable medical devices 

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Home Archive for category "AIMD Companies" (Page 2)
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St. Jude Launches SUNBURST Study to Evaluate New Prodigy Neurostimulator’s Burst Stimulation for Chronic Pain

St. Jude announced today that it has initiated a clinical study of the Prodigy™ neurostimulator, which is the first SCS system able to deliver a proprietary mode of stimulation therapy called burst stimulation. The purpose of the SUNBURST™ (Success Using Neuromodulation with BURST) study is to evaluate whether burst stimulation can be more effective in

 
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Cerbomed’s Non-Invasive Vagus Nerve Stimulator Poses Challenge to Implantable VNS Systems

Cerbomed GmbH, located in Erlangen, Germany, was founded in 2005 to develop transcutaneous Vagus Nerve Stimulation (t-VNS®) neuromodulation systems. Surgically accessing the Vagus Nerve is not trivial, and implanting a VNS system involving cuff electrodes is risky and recovery is lengthy.  Enter t-VNS, which is delivered non-invasively to the auricular branch of the vagus nerve (ABVN), making

 
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Abrupt Increase in Thoratec HeartMate II LVAD Thrombosis Reported in NEJM

A study published on Nov 27, 2013 in the New England Journal of Medicine reports on a sudden increase in the incidence of pump thrombosis with the Thoratec HeartMate II LVAD. The study shows an unexplained increase in thrombosis when comparing LVAD patients at three centers from January 2004 to March 2011 vs. those implanted March

 
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EndoStim’s LES System Approved in Argentina for GERD Treatment

EndoStim announced that Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) approved its Lower Esophageal Sphincter (LES) Stimulation System for Gastroesophageal Reflux Disease (GERD). EndoStim is currently available in Europe, Asia and several other countries in Latin America such as Chile and Colombia.  

 
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Cyberonics Reports Record Sales for its Fiscal Q2 2014

Cyberonics reported $70.1 million in sales for the quarter (fiscal Q2 2014), up around 12% from than $62.9 million booked in the fiscal 2013 second quarter. Net income grew, but at a more moderate pace. It surpassed $13.8 million, versus $13.5 million in net income booked during the same period a year ago.  Operating result highlights for

 
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European Heart Rhythm Association Issues Very Interesting Report on New Devices for the Treatment of Heart Failure

  A position paper was published yesterday by the European Heart Rhythm Association reporting on the performance of new devices for the treatment of heart failure (HF). The report has been endorsed by the Heart Failure Association. The abstract for the paper titled “New devices in heart failure: an European Heart Rhythm Association report” reads:

 
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NanoWattICs Establishes Working Relationship with Rosellini Scientific to Develop Suite of Neurostimulation Devices

ASIC designer NanoWattICs (Uruguay) and Rosellini Scientific (Dallas, TX) have announced they have entered into a collaborative relationship for the development of a suite of neurostimulation devices comprising implantable, wireless and non-invasive technologies.  From the press release: Rosellini Scientific, LLC (“Rosellini Scientific”; Dallas, TX, USA) and NanoWattICs SRL (“NanoWattICs”; Montevideo, UY) are pleased to formally announce

 
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Medtronic Advisa and Revo MRI SureScan Pacemakers Delays Atrial Fibrillation Disease Progression

Results for the MINERVA Trial were presented at the AHA Meeting, showing that  Medtronic Advisa and Revo MRI(TM) SureScan(TM) pacemakers reduce the progression of permanent AF by 61%.  According to the press release: Presented as a late breaking clinical trial at the American Heart Association’s Scientific Sessions 2013, the MINERVA (MINimizE Right Ventricular pacing to prevent Atrial

 
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Medtronic Reports CRM AIMD Sales Trend Showing Stabilization + Strong Earnings from Neuromodulation AIMDs

Medtronic released today its earning reports for the second quarter of fiscal year 2014, which ended October 25, 2013. Medtronic states in the press release: “Second quarter revenue from Implantable Cardioverter Defibrillators (ICDs) was $713 million, an increase of 4 percent on a constant currency basis in a market that continues to show a trend

 
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NeuroPace Receives FDA PMA Approval for for the RNS System to Treat Refractory Partial Epilepsy

NeuroPace is a privately-held company in Mountain View, CA. Their RNS® implantable stimulator, along with depth leads and cortical strip leads are designed for the treatment of medically refractory partial epilepsy. On November 14, 2013, NeuroPace has now received FDA pre-market approval for the NeuroPace RNS System as a treatment for adults with partial onset

 
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Interesting Article in Medical Design Briefs: Designing an ASIC Chip to Control an Implantable Glucose Measurement Device

The current issue of Medical Design Briefs carries an interesting article titled “Designing an ASIC Chip to Control an Implantable Glucose Measurement Device” by Uwe Guenther of ZMDI (Dresden, Germany) and Andrew DeHennis of Senseonics (formerly known as “Sensors for Medicine and Science, Inc.” in Germantown, MD). Zentrum Mikroelektronik Dresden AG (ZMDI), Dresden, Germany, partnered

 
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Boston Scientific Posts 1% Increase in Q3 2013 CRM Sales

From today’s press release: “Improved performance in the company’s Cardiac Rhythm Management and Interventional Cardiology businesses, with CRM achieving growth of 1 percent on a constant currency basis.”  Sales increased from $462M in Q3 2012 to $464M in Q3 2013, which represents a 1% change in constant-currency basis.

 
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St. Jude Q3 2013 AIMD Results: CRM Down 1%, Neuromodulation 3% Up

From today’s press release: Cardiac Rhythm Management (CRM) Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $682 million for the third quarter of 2013, a 1 percent decrease compared to the third quarter of 2012. After adjusting for the impact of foreign currency, total CRM sales were flat. Of that

 
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Neuros Medical Receives IDE Approval to Conduct Pivotal Study

Neuros Medical received an Investigational Device Exemption to conduct a pivotal clinical trial to evaluate the Altius™ System High Frequency Nerve Block technology for the management of intractable limb pain of amputees.   The prospective, randomized, controlled pivotal clinical trial will consist of 130 patients at 15 institutions in the U.S. to evaluate the safety and

 
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St. Jude Acquires Nanostim, Announces CE Mark of World’s First Leadless Pacemaker

St. Jude Medical today announced the completion of its acquisition of Nanostim, Inc., a privately-owned developer of miniaturized, leadless pacemakers. The acquisition adds the world’s first and only leadless pacemaker to the St. Jude Medical product portfolio. According to the press release: Unlike conventional pacemakers that require a more invasive surgery, the Nanostim™ leadless pacemaker

 
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